Mirvetuximab Soravtansine Accountability. Specific details regarding storage and handling of MIRV can be found in the Pharmacy Manual. Accountability and shipping documents for MIRV must be maintained by the Principal Investigator (PI) or designee (eg, the study pharmacist). The Investigator or designee must maintain an accurate record of all MIRV received, stored, dispensed, destroyed, and used in an Investigational Product Dispensing/Accountability Log or equivalent. These records must always be available for inspection, and a copy will be supplied to ImmunoGen on request. Information recorded on the Accountability Log will include dates and quantities of drug received, dates and quantities of drug dispensed, patient number and initials to whom drug is administered, lot number of drug administered, the recorder’s initials, and dates and quantities of drug destroyed or returned. Upon receipt, vials should be visually inspected for vial integrity (ie, cracks or leaks) and a record of any damaged or suspect drug should be kept on the Accountability Log. Upon completion of the study, all MIRV dispatched to a site must be accounted for and unused supplies destroyed according to the site’s Standard Operating Procedures (SOPs) or returned to depot (refer to Pharmacy Manual). The original drug reconciliation records shall be maintained at the site and a copy collected and sent to ImmunoGen or designee once a representative of the company has confirmed the drug accountability. Drug accountability will be monitored.
Mirvetuximab Soravtansine Accountability. Specific details regarding storage and handling of MIRV can be found in the Pharmacy Manual. Accountability and shipping documents for MIRV must be maintained by the Principal Investigator (PI) or designee (eg, the study pharmacist, contract research organization representative, or auditor). The Investigator or designee must maintain an accurate record of all MIRV received, stored, dispensed, destroyed, and used in an Investigational Product Dispensing/Accountability Log or equivalent. These records must always be available for inspection, and a copy will be supplied to ImmunoGen on request. Information recorded on the Accountability Log will include dates and quantities of drug received, dates and quantities of drug dispensed, patient number and initials to whom drug is administered, lot number of drug administered, the recorder’s initials, and dates and quantities of drug destroyed or returned. Upon receipt, vials should be visually inspected for vial integrity (ie, cracks or leaks) and a record of any damaged or suspect drug should be kept on the Accountability Log. Upon completion of the study, all MIRV dispatched to a site must be accounted for and unused supplies destroyed according to the site’s Standard Operating Procedures (SOPs) or returned to depot (refer to Pharmacy Manual). The original drug reconciliation records shall be maintained at the site and a copy collected and sent to ImmunoGen or designee once a representative of the company has confirmed the drug accountability. The clinical trial database shall also record details of MIRV administration such as date and time of administration. Drug accountability will be monitored.
